FDA Approves Valeant Pharma's NDA For Jublia - Quick Facts

(RTTNews) - The U.S.Food and Drug Administration or FDA has approved Valeant Pharmaceuticals International, Inc. 's (VRX, VRX.TO) New Drug Application or NDA for Jublia, a topical triazole antifungal agent, for treating Onychomycosis, a type of nail infection.

Commenting on this, Michael Pearson, Valeant's chairman and chief executive officer said: "We acquired Jublia through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia from pre-IND stage through Clinical Phases 1, 2 and 3." "We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014", he added.

The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has agreed to supply Valeant with the finished dosage form of Jublia for the U.S. market.